For the Consumer

Along with its needed effects, epoetin beta-methoxy polyethylene glycol (the active ingredient contained in Mircera) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking epoetin beta-methoxy polyethylene glycol:

Some side effects of epoetin beta-methoxy polyethylene glycol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Respiratory

Genitourinary

Genitourinary side effects including urinary tract infection (5%) have been reported.[Ref]

Nervous system

Nervous system side effects including headache (9%) have been reported.[Ref]

Musculoskeletal

Musculoskeletal side effects including muscle spasms (8%), back pain (6%), and pain in extremity (5%) have been reported.[Ref]

Other

Other side effects including procedural hypotension (8%), fluid overload (7%), arteriovenous fistula thrombosis (5%), and arteriovenous fistula site complication 5% have been reported.[Ref]

Immunologic

Compared to SC administration, the IV route of administration may lessen the risk for development of antibodies to epoetin beta-methoxy polyethylene glycol (the active ingredient contained in Mircera) In 1789 patients treated with epoetin beta-methoxy polyethylene glycol in clinical studies, antibody testing using an enzyme-linked immunosorbent assay (ELISA) was conducted at baseline and during treatment. Antibody development was not detected in any of the patients.

The incidence of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to epoetin beta-methoxy polyethylene glycol with the incidence of antibodies to other ESAs may be misleading.[Ref]

Immunologic side effects including neutralizing antibodies to erythropoietin, in association with pure red cell aplasia (PRCA) or severe anemia (with or without other cytopenias), have been reported in patients receiving other erythropoiesis-stimulating agents (ESAs) during postmarketing experience.[Ref]